Registration Dossier
Registration Dossier
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EC number: 212-736-1 | CAS number: 865-33-8
Carcinogenicity
Administrative data
Description of key information
Based on the available data on the hydrolysis products potassium hydroxide (CAS 1310-58-3) and methanol (CAS 67-56-1), there is no concern for carcinogenicity of potassium methanolate.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on data from the hydrolysis products methanol and potassium hydroxide, there is no indication or evidence leading to concern for a carcinogenic potential of potassium methanolate.
Additional information
No data are available on carcinogenicity of potassium methanolate. The abiotic hydrolysis of potassium methanolate under aqueous conditions results in the formation of methanol and potassium hydroxide. The latter dissociates into the corresponding cations (K+) and anions (OH-). Therefore, data of the hydrolysis products were taken into account for hazard assessment of potassium methanolate.
According to the OECD SIDS of potassium hydroxide (OECD, 2002), no valid carcinogenicity studies with animals are available. It was concluded that there is no evidence of KOH to be carcinogenic in exposure situations that are relevant for humans (OECD, 2002; OECD 2006). Only at repeated exposure to highly irritant concentrations leading to a prolonged inflammatory response local carcinogenicity due to a non-genotoxic mechanism by direct hyperplasia as a consequence of severe tissue damage could occur, as described in an old mouse skin painting study (25 to 46 weeks of exposure) with irritant concentrations of KOH (3 - 6 %) (RL 3 due to methodological deficiencies according to OECD (2002), therefore not included in IUCLID). For the hydrolysis product methanol, there are studies available, which showed carcinogenicity in mice and rats via the oral or inhalation route (please refer to the endpoint summary of methanol for details). However, the studies have been challenged and it was concluded that methanol is not likely to be carcinogenic in humans.
In conclusion, based on the available data there is no concern for carcinogenicity of potassium methanolate. In addition, the available data on genotoxicity indicate that potassium methanolate and its hydrolysis products are not genotoxic.
References not included as study summaries in IUCLID:
OECD SIDS Initial Assessment Report for SIAM 13 (2002): Potassium Hydroxide (CAS No: 1310-58-3).
OECD SIDS Initial Assessment Report for SIAM 22 (2006): Category of Methanolates: Sodium Methanolate, Potassium Methanolate (CAS No: Sodium Methanolate: 124-41-4; Potassium Methanolate: 865-33-8).
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